Percutaneous entry system and method

ABSTRACT

Apparatus to achieve percutaneous entry to a blood vessel includes several coacting combinations of coacting instruments, some capable of independent action, as well as enabling clear visualisation of the operative area, precise location of the operative site, capture and immobilization of the vessel, and guidance in the positioning and insertion of the puncturing needle Additionally, apparatus is provided for the placement of a sponge directly on the entry wound in the vessel to reduce bleeding. The present invention also sets forth a method for vascular puncture and more particularly for the arterial puncture procedure. The line of maximal pulsation is ascertained, and a small incision in the skin is made. A dissecting-retracting tool ( 100 ) is then employed to create a skin-to-vessel channel. The vessel is inspected through the spread fingers. A tubular access conduit ( 300 ), mounted on an obturator-carrier ( 400 ), is inserted until it rest upon the vessel. The dissector-retractor ( 100 ) is removed and the obturator ( 400 ) is withdrawn from the conduit ( 300 ) leaving the conduit ( 300 ) in place. A needle guide ( 312 ) is then passed down inside the conduit ( 300 ) to contact the vessel. A needle is advanced to the anterior wall of the artery to enter the lumen. A sponge can be positioned with the conduit pressed against the puncture site to reduce bleeding.

This application claims the benefit of provisional application Ser. No.60/152,745 filed Sep. 8, 1999.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical procedures and instruments, andmore particularly to apparatus and methods for dissection of tissue fromskin to an underlying blood vessel or body structure, and the methods ofaccomplishing such dissections and arterial and venous punctures.

2. Description of the Prior Art

Present surgical practice for percutaneous puncture of the femoralartery with entry into the arterial venous lumen is a blind approach.The same is true for other arteries and veins accessible via the skin.These procedures have become ever more common and are frequent duringprocedures relating to invasive cardiology, invasive radiology, andcardiac surgery.

Currently, puncture of a femoral artery is accomplished by first feelingthe pulse through the skin and underlying tissue; a trajectory or pathfor the needle is thereby estimated by the practitioner to properlyengage the artery. The needle is then advanced toward the artery throughthe skin, and it is hoped that the needle will puncture the artery inits mid-line, which is optimal. However, often the needle will puncturethe artery in an off-center position, or the artery may be missedentirely, and multiple attempts executed before success. Further, if theartery is punctured off-center this is not evident. Thus, in general,the quality of the puncture is not known.

An off-center puncture makes insertion of the catheter more difficultand increases the likelihood of arterial trauma and tearing of thevessel wall, resulting in more difficult hemostasis at the end of theprocedure. Many factors interfere with a successful mid-line puncture,leading to an off-center puncture or missing the artery entirely.Subcutaneous tissue, particularly if fibrous, may deflect the needlefrom its intended path. Thicker subcutaneous tissue, as found in obesepersons, increases the difficulty of accurately assuming the trajectoryof the needle and resulting puncture of the artery, as well as deprivingthe operator of feeling that the puncture is actually occurring.Additionally, it must be estimated as to when the needle has actuallyentered the artery. Hence, many operators may push the needle throughthe rear wall without realizing that this has occurred.

Because of the uncertainty as to the location of the intersection of theneedle with the artery and entry of the needle tip into the true lumenof the artery, many operators will intentionally push the needle to agreater depth so that the rear wall is also punctured (double-wallpuncture), and then withdraw the needle slowly while awaiting the pulseof blood through the needle's open channel to indicate that the tip ofthe needle now lies inside the arterial lumen.

The difficulties enumerated above with respect to percutaneous vascularpuncture are exacerbated when attempting a venous puncture, sincepronounced pulsations to define the vessel are absent, and venous wallsare thinner, hence more easily damaged. Also, venous entry (e.g.jugular, subclavian) relies heavily on superficial anatomic landmarks,which are less precise.

Percutaneous entry of a blood vessel is facilitated by instruments orapparatus that dissect a channel or path from skin to vessel, therebyeliminating tissue resistance to guidewires, catheters, or otherimplements. The geometry of contemporary instruments is such that thehandles of the instrument, as held by the operator, and the joint of theinstrument obstruct and prevent a clear view of the tips and the pathwaythey are creating.

It is important that a dissecting instrument provide a clear,unobstructed view of the dissecting tips and the channel createdtherefrom. For a dissecting instrument to provide such visualization ofthe subcutaneous channel and the underlying blood vessel, the grippinghandles must be offset from the dissecting blades or fingers in such away as to provide a direct and clear line of sight down to the tips ofthe instrument and hence an unobstructed view of the surgical site.Additionally, the channel created by the fingers must be broad enoughfor visualization to occur.

Another problem associated with percutaneous entry into a blood vesselis the bleeding that results. After the needle is removed and/or anyother invasive removed from the blood vessel, it is necessary to closethe general area of the entry on the vessel. This, however, is not acompletely successful method of preventing the bleeding. Since thepressure is applied externally on a relatively large area, there isalways seepage resulting in bruising or even the buildup of adhesionsfrom the internal blood.

Numerous surgical implements have been developed which would be usefulin connection with the procedures to be accomplished by the presentinvention. However, none of these tools show or disclose configurationswhich meet the requirements for the procedures as set forth in thepresent invention. Some of the prior patents dealing with this subjectmatter are as follows.

U.S. Pat. No. 5,797,939 to Yoon discloses an endoscopic scissor. Notethat the finger loops of the handle are at an angle to the main shaft,and that they are spread when the cutting blades are open, and alsospread when the cutting blades are closed. (See FIG. 3). Additionally,the cylindrical tubular section of the device allows for passage ofaccessories to the end of the blades.

U.S. Pat. No. 5,356,408 to Rydell discloses a bipolar electrosurgicalscissor instrument in which the handles are offset at 90° and remain inan apparently open position when the blade itself is closed.Additionally, the blades are bent at an angle to the linear axis of thedevice to provide for an unobstructed view of the cutting area. Thisactually is the closest reference to two of the features of the presentinvention, namely, the angle of the fingers and the position of thefinger loops.

U.S. Pat. No. 5,153,997 to Chiavaras et al. discloses ergonomic scissorsin which the finger grips are at right angles to the blade.

U.S. Pat. No. 4,889,112 to Schachner et al discloses a tracheostomyenlarging tool, which has offset probing fingers 107 and 108. Thesefingers have passage means in them to surround a wire which has beeninserted into the trachea to guide the fingers into the trachea so thatthe passage into the trachea can be enlarged to widen the opening.

U.S. Pat. No. 4,819,636 to Gerich et al discloses a device for cuttingand squeezing tubing, in which the finger mounts and the handles areoffset from the cutting blades or working arms of the instrument.

U.S. Pat. No. 4,140,124 to Curutchet discloses a surgical instrumenthaving an offset handle with special means for holding the thumb and thefingers in a ergonomic position. This patent does not have the sameorientation of the handles as does the present invention.

U.S. Pat. No. 4,049,002 to Kletschka et al. discloses various scissorsor clamps having fluid passages in the handles to allow fluid to bedirected towards the tip of the implement. However, note that thepassages are internal and are not used to coact with each other to forma cylindrical pathway between the blades.

U.S. Pat. No. 3,987,542 to Visco discloses scissors with off-sethandles. Additionally, although not for the same purpose, the blades ofthe scissors have tubular sections. These are more for strength than forany functional purpose.

U.S. Pat. No. 1,214,562 to McGrath discloses lawn power sheers, whichhas off-set blades to the body portions 14 of the levers.

U.S. Pat. No. 331,179 DES to Omichi discloses hair-cutting scissors witha curved blade.

U.S. Pat. No. 310,714 DES to Dolwick discloses a surgical or dentalscissors having the finger loops bent at an angle from the main shaft ofthe device and having the blade portions bent similarly to form anotherangle so as to make the device a double curved instrument with thehandles somewhat parallel to the blades and the main shaft at an angleto both.

U.S. Pat. No. 258,714 DES to Backstrom discloses nail scissors havingcurved cutting blades.

U.S. Pat. No. 239,910 to Megna discloses scissors having bent fingerloops.

U.S. Pat. No. 231,034 DES to Moore discloses a surgical clamp with bentfingers.

U.S. Pat. No. 2,191 to Pitney discloses a speculum having fingers AAwhich coact with the handle BB for spreading. FIG. 2 shows a levator,which is used to examine the anus once the fingers AA of the speculumare inserted.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, to achieve the desired visualization of the operative siteand the proper positioning of the needle to achieve the most effectivepuncture of a vessel, the present invention sets forth several coactingcombinations of coacting instruments, some capable of independentaction, as well as enabling clear visualization of the operative area,precise location of the operative site, capture and immobilization ofthe vessel, and guidance in the positioning and insertion of thepuncturing needle.

Visualization of the operative area is accomplished by means of adissecting-retracting tool with the hand-gripping and controllingmembers of the tool offset in two dimensions from angled bluntdissecting fingers to create a subcutaneous path from skin to vessel,providing a clear line of sight through the dissecting fingers to theirvery tips. Once visualized that dissection has occurred, conduit andobturator/carrier assemblies are matingly positioned within the bluntdissecting fingers to register with the ends of the dissecting fingersat the site of the blood vessel. The terminal ends of the conduit andobturator are angled and concavely shaped to conform to the vessel, andcenter the assembly on top of the vessel to be punctured. Thedissector-retractor is removed and the obturator is then removed leavingthe conduit in place and thus providing an open channel from skin tovessel surface. The conduit bears along its lower, inner surface a finelongitudinal groove capable of guiding a needle tip to the center of theblood vessel or, alternatively, guiding a light probe to illuminate thepuncture site. This light probe along its upper surface carries a finelongitudinal groove that is also capable of guiding the needle to thecenter of the blood vessel. The light probe is centered within theconduit by mating a raised ridge along the longitudinal axis on theunderside of the probe with the longitudinal groove located on thesurface of the conduit. Centering of the illumination probe on thevessel is facilitated by a forked tip which captures the blood vesselequally on either side of the midline of the probe, and in the case ofan artery, transmits arterial pulsations in a manner that enables theoperator to feel that the illumination probe has captured and iscentered on such artery.

Additionally, apparatus is provided for the placement of a spongedirectly on the entry wound in the vessel. A sponge is positioned withinthe conduit and a sponge pusher pushes the sponge to the site of theentry where pressure is applied by the pusher directly on the sponge atthe site of entry to reduce the bleeding upon removal of the invasiveitems from the vessel.

These features facilitate a preferred single-wall puncture of the vesseland discourage the more harmful double-wall puncture.

The present invention also sets forth a method for vascular puncture andmore particularly for the arterial puncture procedure. The operatorbegins by palpating an artery, such as the femoral artery. The line ofmaximal pulsation is ascertained, and a small incision in the skin ismade. A dissecting-retracting tool is then employed to create askin-to-vessel channel until the vessel to be punctured is reached. Thetips of the dissecting-retracting tool then rest upon the vessel to bepunctured, the blood vessel is palpated, and the fingers are spread intoan open position by squeezing the handles toward one another. The vesselis inspected through the spread fingers. A tubular access conduit,mounted on an obturator/carrier, is inserted and advanced until it ispositioned by the contoured ends of the conduit and obturator restingupon the artery with the concavity matching the radial curvature of thevessel. The dissector-retractor is removed over the obturator leavingthe obturator and conduit in place. The obturator is then withdrawn fromthe conduit leaving the conduit in place. A flexible collar is wrappedaround the protruding end of the conduit and adhesively affixed to theskin to stabilize the conduit and maintain its position. A light-probeis then passed down inside the conduit to contact the vessel. The forkedtip of the light probe engages the surface of the vessel to transmitpulsations from said vessel in a manner that will permit the operator tofeel that the probe is properly centered on the vessel. A longitudinalgroove running the entire length of the upper surface of the probe toits tip allows a needle to be advanced to the anterior wall of theartery to enter the lumen. With the needle properly positioned withinthe arterial lumen, a guidewire is inserted via the needle into thelumen, after which the needle and probe are removed leaving theguidewire in place. The conduit can remain in place for the entireprocedure to maintain a tissue-free channel, or can be removed over theguidewire.

Accordingly, it is an object of the present invention to provide a groupof coacting tools, some capable of independent action, which facilitatepercutaneous vascular entry by efficiently enabling accuratepercutaneous puncture of blood vessels.

It is another object of the present invention to eliminate double-wallpunctures of vessels, to more accurately locate and position the needlefor puncturing a vessel, to enable visualization of a vessel prior topuncturing the vessel in order to reduce the number of attemptsnecessary to successfully puncture a vessel.

It is another object of the present invention to minimize trauma andtearing of the blood vessel during puncture.

It is another object of the present invention to avoid mis-positionedpunctures in the side of a vessel.

It is another object of the present invention to provide adissecting-retracting tool having handles which are both angled andoffset for increased comfort during squeezing action, due to thedesigned range of motion from opened to closed position.

It is another object of the present invention to provide adissector-retractor for vascular puncture having laterally offsethandles positioned to the side of the device, out of the direct line ofsight, in order to provide unobstructed viewing of dissection.

It is another object of the present invention to provide adissecting-retracting tool that spreads tissue as handles are squeezedand are moved to a closed position.

It is another object of the present invention to provide adissector-retractor having a spread power grip which provides maximumsqueezing force by allowing the handles to remain in a slightly openposition (i.e., full dissection) when the instrument fingers are in thefully open position and thus, the range of separation of the tips iswithin the range of maximum strength for the gripping/squeezing actionof the hand.

It is another object of the present invention to provide adissector-retractor having angled fingers for unobstructed viewing ofdissection. The instrument fingers are at a 20° to 80°0 angle to theplane of the dissector handles, moving them out of the plane of thehandles and the hand of the operator, and can be located on a planeabove or below the level of the handles.

It is another object of this invention to provide a dissector-retractorhaving dissecting fingers capable of spreading underlying tissue tocreate a broad, clear channel down to the blood vessel.

It is another object of the present invention to provide adissector-retractor having tapered fingers with tapered cylindricalpassages formed in the fingers to create a cylindrical channel down tothe blood vessel when the fingers are in the fully open position.

It is still another object of the present invention to provide adissector-retractor whose dissecting fingers at the tips taper to apoint to allow for easier dissection in both the downward and forwarddirection. Further, the bottom-to-top angle of the ends of the fingersmatch the angle of entry, and the side-to-center angle on the lateralsurfaces of the fingers facilitates blunt dissection used in thefingers.

It is still another object of the present invention to provide adissector-retractor having three-point stabilization of the apparatuswhen articulating the fingers by means of the index finger in anadvanced foremost position, the thumb in a rear position, and theremaining fingers in another rearward position. This allows the indexfinger to apply downward pressure on the tips during dissection, andaccurately control the direction of entry, thereby gaining greatercontrol in manipulating the instrument.

It is another object of the present invention to provide adissector-retractor having a contoured finger cup thereby allowing theindex finger to apply forward and downward pressure on the tips duringdissection, as well as overall stabilization of the instrument.

It is another object of the present invention to provide adissector-retractor having a contoured finger rest for the index fingerwhen not located in the actuating position.

It is another object of the present invention to provide adissector-retractor having depth markings on the dissecting fingerswhich indicate the depth of the dissection, and hence the selection oflengths and types of coacting apparatus in accordance with the depthshown on the markings.

It is another object of the present invention to provide a dissectorretractor having a locking mechanism that holds the dissecting tips opento a specific position.

It is another object of the present invention to provide adissector-retractor which allows for a clear path of sight through thespread dissecting fingers to the very tips of the dissecting fingers.

It is another object of the present invention to provide a dissectorretractor having spread instrument handles which allows for operationover the strongest range of thumb-to-finger and/or hand position, thusallowing the greatest force with the least exertion.

It is another object of the present invention to provide anaccess-conduit for use with a dissector-retractor, which creates an openchannel from the skin surface down to the blood vessel and coacts with achannel formed by the blunt dissecting fingers.

It is another object of the present invention to provide anaccess-conduit having a central longitudinal groove to guide anilluminated light probe or needle down the center of the tube to thecenter of a blood vessel. Further, this groove is also used to orientthe access-conduit when coacting with the obturator.

It is another object of the present invention to provide anaccess-conduit having an angled and curved distal tip, a top-to-bottomangle to match the angle of entry and a side-to-side curve to match thecurve of the blood vessel, to capture a blood vessel and center the tubeover the blood vessel.

It is another object of the present invention to provide anaccess-conduit adapted for use with a dissector-retractor which can bemade in several lengths to match the appropriate skin-to-vessel distancenecessary to contact the blood vessel involved.

It is still another object of the present invention to provide anaccess-conduit made from material which is light-transmitting to conveylight through the walls of the tube to the vessel and/or to be made froman opaque material with an opaque surface to reflect light directed downthe access-conduit towards the blood vessel.

It is still another object of the present invention to provide anillumination probe to illuminate the channel down to the blood vessel aswell as to be used for locating the vessel by feeling for the pulse withthe tip of the probe or to explore the vessel to determine if the vesselis unsound.

It is still another object of the present invention to provide anillumination probe having an angled/curved distal tip to fit over theblood vessel and feel the pulsations of the vessel, the distal tiphaving a top to bottom angle to match the angle of entry of the probeand having a side to side curve to match the curve of the blood vessel.

It is still another object of the present invention to provide a needleguide probe having a longitudinal channel that acts as a guide for aneedle down the centerline of the probe to the center of a blood vesselto allow for a central puncture.

It is still another object of the present invention to provide a needleguide probe having a grooved channel which acts as a guide for a needledown the center of the guide to the center of the blood vessel to allowfor a central puncture.

It is still another object of the present invention to enable coactionof positioning between the access-conduit and the needle guide probe,and the needle guide probe with the access-conduit.

It is still another object of the present invention to provide for anillumination probe made of a material which can be illuminated, andwhich transmits light through the body of the illuminating probe to itsdistal end to illuminate the operative site.

It is still another object of the present invention to provide for anillumination probe which can be made from opaque material with an opaquesurface to reflect light directed down the conduit towards the vessel tobe punctured.

It is still another object of the present invention to provide anobturator which can hold one or two conduits, with each conduit on anopposite end with the conduits being of dissimilar size and/or shape.

It is still another object of the present invention to provide anobturator which is constructed to properly insert a conduit in anappropriate orientation with respect to the vessel to be punctured.

It is another object of the invention to provide an obturator withopposite ends rotated 180° in relation to each other so that the angleat the distal tip at one end is parallel to the angle at the distal tipof the other end, thus providing an end surface that is parallel to theskin to assist in proper visual orientation of the conduit/obturatorassembly.

It is still another object of the present invention to provide anobturator having a mid-section configured to allow for removal of thedissector-retractor from a coacting conduit/obturator assembly.

It is still another object of the present invention to provide anobturator that includes a retention mechanism to hold the conduit inposition during manipulation of the conduit/obturator assembly.

It is still another object of the present invention to provide anobturator which is constructed to facilitate action by the operator toeasily and accurately push the conduit and release same from theobturator.

It is still another object of the present invention to provide anobturator which is constructed with a partial shoulder to act as a stopfor the access-conduit as it is being placed and held on the obturator,and to allow for access to the end of the conduit.

It is another object of the present invention to provide an obturatorhaving an angled and curved distal tip to capture the blood vessel, andhold the obturator in place. The distal tip is angled from top to bottomto match the angle of entry and is curved from side to side to match thecurve of the blood vessel.

It is still another object of the present invention to provide anobturator which is constructed having a depression to allow for accessto the end of the conduit.

It is another object of the present invention to provide a method forpuncturing a blood vessel which provides for coaction between adissecting retracting tool, a conduit mounted on an obturator and aneedle guide path in appropriate sequence to enable clear visualizationof the channel from the skin incision to the blood vessel to bepunctured and/or accurate positioning of the puncture in the vessel.

It is another object of the present invention to provide a method whichallows for capture of the blood vessel by the distal end of the conduitand obturator.

It is another object of the present invention to provide a method whichallows for capture of the blood vessel by the needle-guide probe.

It is another object of the present invention to provide a method whichallows palpation of the blood vessel by transmission of the pulse alonga needle-guide probe from the blood vessel to the operator.

It is another object of the present invention to provide a method whichallows palpation of the blood vessel by transmission of the pulse alongan obturator from the blood vessel to the operator.

It is another object of the present invention to provide a method whichallows palpation of the blood vessel by transmission of the pulse alongthe dissector-retractor from the blood vessel to the operator.

It is another object of the present invention to provide apparatus toenable application of specific localized pressure to the site of apercutaneous entry of a blood vessel.

It is another object of the present invention to provide apparatus forreducing the bleeding at the entry site of a vessel by directapplication of a sponge to the site of the vessel opening.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, referencemay be had to the following description of exemplary embodiments of thepresent invention considered in connection with the accompanyingdrawings, in which:

FIG. 1 is a perspective view showing the blunt dissecting tool of thepresent invention in the closed position;

FIG. 2 is a view of the blunt dissecting tool shown in FIG. 1 with thedissecting fingers in the open position;

FIG. 3 is a view of the arm having the finger grips of the bluntdissecting tool shown in FIG. 1;

FIG. 4 is a view of the blunt dissecting tool of FIG. 1 together withcoacting conduit and obturator;

FIG. 5 is an enlarged view of FIG. 4;

FIB. 6 is an enlarged view of the tips of the fingers of the bluntdissecting tool shown in FIG. 1;

FIG. 7 is a view similar to FIG. 4 with the blunt dissecting toolremoved up along the obturator in a position for separation from theobturator and conduit assembly;

FIG. 8 shows an enlarged view of the end of the conduit shown in FIG. 11from the front;

FIG. 9 is an enlarged view of the end of the needle guide shown in FIG.13;

FIG. 10 is a view showing the needle guide within the conduit;

FIG. 11 is an enlarged view of the conduit;

FIG. 12 is an enlarged view of the obturator; and

FIG. 13 is an enlarged view of the needle guide.

FIG. 14 is a view showing the elements used for reducing the bleedingfrom a percutaneous entry to a vessel.

FIG. 15 shows the elements of FIG. 14 in the working relationship.

FIG. 16 shows the bottom of the conduit shown in FIG. 14.

FIG. 17 shows the bottom of the conduit from the front elevation.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in FIG. 1, a dissector/retractor tool is generally indicated at100 and has 2 arms generally indicated at 110 and 120. The arms end infingers 130 and 132 which are bent from the plane of the arms at anangle 131 of anywhere from 20° to 80° but preferably from 30° to 45°.The ends of the fingers 134 and 136, respectively on fingers 130 and 132have points 138 and 140 which are pointed but not sharp and not rounded.The points are chamfered at the bottoms 142 and 144, respectively. Thechamfer provides an angle which is supplementary to the angle of thefingers to provide a flat plane with the horizontal. Chines on the flatplane at the outside lower leading surface of the fingertips 146 and148, respectively provide for a sharp bottom when the dissecting fingersare acting together.

As shown in FIG. 2, moving the arms of the dissector-retractor togetherwill spread the fingers. The fingers of the dissector-retractor, asshown in FIGS. 2 and 3, have tapered cylindrical passages formed on thefacing surfaces so that when the fingers are spread to the maximumposition, a cylindrical path is formed from the top of the arms to thetips of the fingers. The tapered cylindrical passages are indicated at152 and 154 on the inner surfaces of thumb and finger arm 110 and 120,respectively. This cylindrical passage will allow a clear line of sightfrom the base of the fingers down to the tips 138,140.

As seen in FIG. 1, depth marking indicia 160, herein enumerated in mm.,are formed on the top surface of the fingers and are oriented forviewing from the finger-grip portion. These indicia are an indication ofthe depth of tissue that has been penetrated by the fingers of thedissector-retractor. This provides an indication to the operator as tothe length, of conduit that will be necessary for the next step in theprocedure.

The handle portion of the dissector-retractor, generally indicated at170, contains a finger grip 172 possessing an oblong opening for two,three or four fingers. The finger grip is at an angle 176 to the thumbgrip to provide the most comfortable position of the partially closedhand while holding the device.

Additionally, the offset of the finger grip provides for clearunobstructed view over the arms, especially dissecting fingers of thedissector-retractor. There is a chamfer 178 on the inner surface of thefinger grip to provide a smooth radius for comfort of the hand. Thethumb grip 182 has a chamfer 184 on the inside of the grip. There is aspace 190 between the finger grip and the thumb grip when the dissectingfingers of the arms are in the maximum open position. This space ordistance provides a position in which the fingers and the thumb areseparated for the maximum strength of grip for the human hand.

The chamfered slopes on the sides of the hand grips, 178 for the fingersand 184 for the thumb, provide for maximum comfort. There is a also aforefinger stabilizing function generally indicated at 192.

The forefinger-stabilizer includes a resting position 194 for theforefinger when this finger is not being used for any special purpose,and a forefinger well or cup 193 which has a forward wall 196. Thepurpose of the forefinger well is to allow a position where theforefinger can be placed to exert force without slipping in controllingthe dissector-retractor without slipping. The front wall 196 allows theforefinger to press downward and forward on the dissector-retractor.Together, the forefinger-well 193, the thumb 182, and the finger grip172, establish a three-point stabilized position for holding andcontrolling the dissector-retractor during use.

Note that the forefinger-well 193 is displaced to the side of thedissecting fingers to maintain a clear line of sight to the cylindricalpassage formed in the dissecting fingers when they are spread.

As shown in FIGS. 2 and 3, a spring mechanism generally indicated at200, as shown on FIG. 2 or 3, having a spring with recessed channels204,206 for the spring is provided to cause the fingers of the dissectorretractor to rest normally in the closed position with the hand grips inthe most widely spread position.

A locking bar 210 is mounted in a storage position on the thumb arm,there being two detents 212 or bore holes to hold the ends of thelocking bar 210 in a passive non-utilized position. When it is desiredto maintain the dissecting fingers in a spread position, the locking bar210 can be placed in bore holes 211 and 213 on the arms 110 and 120,respectively, to hold the arms apart in the spread position against theaction of the spring. Alternatively, a locking bar can be used to engagecut-outs 215,217 on the sides of the arms to hold the position withdissecting fingers.

As shown in FIG. 4, two conduits 300A,B are mounted on an obturatorgenerally indicated at 400. The conduits on the obturator fit within thecylindrical passage formed in the spread fingers of thedissector-retractor. Note that conduit 300A is longer than conduit 300B,as was previously discussed in connection with the markings 160 on thetop face of the dissecting fingers. The diameters of the obturator endsand associated conduits can also vary.

FIG. 5 is an enlarged view showing the lower conduit on the obturatorwithin the cylindrical passage.

As shown in FIGS. 8 and 11, once the conduit is moved or advanced downto the bottom of the dissecting fingers, and is positioned over theblood vessel to be punctured, the matching curvatures at the bottom ofthe obturator and the bottom of the conduit respectively, will help theconduit find or position itself on top of the vessel. See FIGS. 8 and 11for enlarged views of the conduit and FIG. 12 for an enlarged view ofthe obturator.

In FIG. 11 , the conduit generally indicated at 300 has an end contouror profile adapted to coact with the surface of the blood vessel. Thediameter of the conduit generally indicated at 302 extends for a length304, which coincides with the length of the wide end of the obturator tomaintain the conduit fully on the obturator while it is being insertedthrough the cylindrical passage of the dissecting fingers. The conduitcreates an open access channel from the skin surface down to the bloodvessel. The tip is scooped out at 308 so as to have a left to rightcurvature that will conform to the surface of the blood vessel andcontinue to engage the vessel even if the conduit is raised to a greaterangle than its intended angle of entry.

Additionally, a guide channel 312 in the conduit acts to align itselfand receive a guide rib 420 on the obturator to align the conduit withthe obturator, as will be discussed further below.

The angle at the bottom of the conduit is the same angle as the bottomof the dissecting fingers and will be the same as the bottom of theobturator which is supplementary to the angle of the dissecting fingerso as to provide a generally horizontal flat surface to lie fully incontact with the vessel to be punctured.

As shown in FIG. 12, the obturator generally indicated at 400 has a longend 402 and a shorter end 404. We will describe only the longer end forpurposes of brevity. The longer end has an end 406 possessing a profilesimilar to that of the conduit in that it has a chamfer anglesupplementary to the angle of the dissecting fingers and equal to thatof the conduit, and is also curved from side to side to facilitatecontact with the rounded surface of the vessel to be punctured. Theopposite end 407 has a profile similar to end 406 but rotated 180° toprovide an end surface parallel to the opposite end surface. Theparallel opposing end surfaces aid in visual orientation of theobturator/conduit assembly in the dissector-retractor tool.

The obturator has a guide rib 420 running the length of the largerdiameter section 402 and which is adapted to coact with a guide groove312 in the conduit to position the conduit and prevent rotation of theconduit. A tab 430 formed in the larger section of the obturatorprovides a spring friction contact with the conduit to prevent movementof the conduit with respect to the obturator.

A stopping shoulder 440 is provided at the end of the wide section ofthe obturator to prevent the conduit from backing up onto the obturator.Additionally, an arrow pointer shown as 450 on the smaller end of theobturator but which also appears on the other end, provides a tactilecontact to give the operator an indication of the orientation of theobturator and conduit assembly. A depression 460 in he obturator allowsthe finger access to the end of the conduit when pushing conduit offobturator.

As shown in FIG. 5, the conduit/obturator assembly is placed within thetubular channel created by the spread fingers of thedissector-retractor. Subsequently, the dissector-retractor is withdrawnby sliding the dissector-retractor up the conduit as shown in FIG. 7until it reaches the narrow central section of the obturator 410, atwhich point the obturator will fit loosely in the cylindrical channelcreated by coaction of the cylindrical channel formed in the dissectingfingers, and this will facilitate removal of the obturator from thedissector-retractor. The obturator is then removed from the conduitleaving the conduit in place.

As shown in FIGS. 9,10 and 13, a needle guide-illuminator is providedwhich is adapted to fit within the conduit once the obturator has beenremoved.

As shown in FIG. 13, the needle guide-illuminator is generally indicatedat 500 and has two panels or wings 510,520 which form a trough or groove530 to guide a needle from the handle portion 550 down to the end of theguide 540. The end of the guide 540 has two tips 542 and 544 which areformed by the end of the guide and which have a scooped out portion sothat the ends of the guide 542,544 will overlie and capture between theman underlying blood vessel or body structure.

Additionally, the panels 510,520 form a concavity upward. When fittedwithin the conduit as shown in FIG. 10, the needle- guide illuminatorhas a stop member 560, which will position the needle guide so that theend 540 is in registration with the end of the conduit 306, and a ribguide 580 on its underside to align it properly within the conduit.There is an attaching point 570 on the handle of the needle guideilluminator for attachment of a fiberoptic bundle. Also there is aroughened or beaded finger grip 552, offset from the guide path 530 onthe handle 550, for manipulation of the light guide.

Because of the longitudinal play between the needle guide and theconduit, the needle guide will be capable of movement with a pulsatingvessel, such as the femoral artery, and this will be transmitted to theoperator who is gripping the handle. He will then be able to manipulatethe needle guide to position it on the blood vessel to be punctured andwill be able to see down to the point of the puncture through theconduit.

The conduit and the needle guide can be made of optically clear materialso that a fiberoptic bundle when attached to the end of the needle guidewill provide a stream of light within the conduit that will illuminatethe operative site of the puncture.

Additionally, the conduit and the needle guide can have an innerreflective surface that will help reflect light within the conduit tofurther enhance the illumination of the puncture cite.

The method of use can now be discussed. The operator begins by palpatingthe femoral artery. The line of maximal pulsation is ascertained, askin-to-artery trajectory is pictured, and a small incision in the skinis made with a blade. The dissector-retractor is now employed to createa skin-to-vessel channel. The point of the tips of the dissectingfingers are inserted through the skin incision at a desired angle(usually between 30° and 45°) and advanced by forward pressure directedby forefinger, alternating with squeezing of the handles to open thedissecting fingers, thereby performing a blunt dissection until thefemoral artery is reached.

The under-surface of the tips is configured to be parallel to the arteryso that upon reaching this vessel, the closed tips can rest upon andcontact the artery and transmit arterial pulsations. At this point thedissecting fingers are opened, the channel can be illuminated and theartery inspected visually, if desired.

Having ascertained by palpation and/or visualization that thesubcutaneous channel has reached the femoral artery, the tubular accessconduit is inserted (with the use of the obturator) between thedissectors fingers down to the arterial surface. The configuration ofthe conduit's distal end, angled to parallel the artery and concaveleft-to-right to match the radial curvature of the vessel, permits thecoacting distal ends of the conduit and obturator to engage the arterialsurface and capture it in precise alignment. Slight downward pressurepermits appreciation of the arterial pulsation and verification that theconduit is centered in the artery. The dissector/retractor is nowremoved over the obturator leaving the obturator with the conduit inplace.

The obturator is then withdrawn from the conduit and the obturator isset aside. A flexible collar is wrapped around the protruding proximalend of the conduit and the adhesive-bearing wings pressed against theskin, thereby stabilizing the position of the conduit. The channelprovided by the conduit is ample for irrigation and suction, if and whenneeded, to enhance visualization of the vessel and its pulsations.Additional light may be introduced into the conduit by an externalfocused lamp, such as those designed to be worn on the forehead, or theillumination may be provided by attaching a fiberoptic source to itsproximal end.

The illumination probe is then passed down the conduit along its bottomsurface where it is guided by a thin channel in the conduit. When thecontoured tip of the illumination probe-needle guide engages thearterial surface, the transmitted pulsations can be firmly felt,particularly if the probe is pressed slightly against the artery. If theprobe is illuminated, the artery and its pulsations can be visualized,and proper left to right centering of the probe over the artery can beverified.

When the vessel is illuminated and visually inspected, disease of thearterial wall may be recognized, in which case the operator may chooseto move up or down the artery to a more suitable point of entry, thusavoiding any arteriosclerotic plaque.

The upper surface of the probe bears a fine groove running its entirelength and over the distal contoured tip. This groove can be visualizedand is centered on the artery. The needle tip is placed in the grooveand slid down the entire length of the probe and then centrallypunctures only the anterior wall of the artery to enter the lumendirectly, and a double wall puncture is avoided.

When blood pulsation through the needle verifies proper entry into thevascular lumen, the guide wire is inserted. Then the probe and needleare removed. The operator must decide at this juncture whether to leavethe conduit in place for the entire procedure. If not, then the conduitmust be removed over the guide wire following the needle. The role ofthe PERCUTANEOUS ENTRY SYSTEM in the arterial puncture is now completed,and the access procedure can now be continued according to standardpractice with dilating catheter and sheath passing over the guide-wireinto the vessel.

From the above discussion one can appreciate the value of vascularpuncture under direct palpation and/or observation, where the artery isclearly visualized, its pulsation is clearly seen and topical. Also theartery is distinguishable from the adjacent femoral vein and nerve,which can be damaged by offline passage of the needle. The PERCUTANEOUSENTRY SYSTEM of the present invention provides a new and superior methodfor the percutaneous introduction of catheters and other medicalinstruments into the vascular system under direct palpation and/orvision. The unique features of the system enable a truly centralpuncture of the blood vessel at the desired angle of entry, therebyminimizing trauma to the vascular wall and adjacent structures.

FIGS. 14,15,16,17 show apparatus for a closure pressure sponge assemblyto be used with the blunt dissecting apparatus for percuteaneous entrythrough blood systems.

Since percutaneous entry into a blood vessel requires a puncture of theblood vessel, it may result in an irregular puncture. The puncture musteventually be closed for hemostatis. The traditional method has been toapply gross pressure to the area of the puncture. The process is notlocalized because force is applied to a broad area of skin.Complications, particularly hematoma of various sizes, are common.

To reduce this problem, the present invention provides an add-on kit forthe percutaneous dissecting and access system which includes a tubularconduit generally indicated at 600 which provides a clear cylindricalpath from the skin of the patient to the vessel that has been entered.Thus direct pressure that is specific and localized to the entry site ispossible. An obturator or sponge pusher generally indicated at 800 isalso included. The sponge pusher or obturator is intended to exertpressure directly and exclusively at the site of the entry into thevessel to maintain pressure for a length of time needed for clotting andhemostatis of the vessel puncture site.

Lastly, a “sponge” generally indicate at 700 which may be of a non-wovenstructure, or a woven gauze-like mesh design, and may also be of abioresorbable material, is intended to be inserted into the conduit. Thesponge pusher would follow behind the sponge to deliver the sponge tothe site of the entry and exert a resilient force at the desired site.The sponge pusher would maintain light pressure on the sponge and henceon the vessel that has been entered until natural hemostatis occurs.

Upon accomplishing hemostatis, the bioresorbable sponge may be removedor could be left in place. To facilitate removal of the sponge it may benecessary to stitch the sponge with a long suture generally indicated at710 prior to its insertion into the conduit. In this way, the operatorcan remove the sponge simply by tugging on the suture.

It should be noted that bottom of the conduit is similar to the bottomof the conduit previously described. The distal end 610 is cut at anangle which would enable the distal end to lie flat at the angle ofpercutaneous entry.

Additionally, the cut of the angle through the cylindrical conduitproduces an oval shape having a long axis intended to lie parallel tothe vessel being entered and the bottom also has a curved surfaceperpendicular to the long axis 620 of the oval formed at the bottom. Thecurve 630 enables the conduit to lie relatively flat on the vessel to beentered or which has been entered.

The very tip of the conduit 640 is also opened up to enable the conduitto lie and find the vessel that it is to coact with.

The pusher could be similar to the obturator previously discussed. Thenecessary elements of the pusher are a distal end 810 having a bottomsurface 820 similar to the bottom surface of the obturator previouslydescribed and adapted to form the same angle as the distal end of theconduit and have a shape complementary to that of the distal end of theconduit to form a continuous surface with the end of the conduit so thata uniform pressure can be applied to the sponge so as to have the spongeseek around or curve with the surface of the vessel that has beenentered.

Therefore, the bottom of the pusher will be oval in shape similar tothat shown in FIG. 16 having a long axis and a short axis with a curvedportion perpendicular to the long axis to allow it to rest with agreater surface area on the vessel to be entered. This shape will thenpush the sponge into greater conformity with the surface of the vessel.The length of the pusher must be sufficient so that an end of the pusherwill extend from the end of the conduit when the sponge has been pusheddown to the bottom of the conduit and is resting on the vessel.

The advantage of direct visualization may be even more valuable forvenous entry, since pronounced pulsations to define the vessel areabsent and venous walls are thinner, hence more easily damaged. Alsovenous entry (for example into the jugular or subclavian) relies heavilyon superficial anatomic landmarks which are less reliable than directvisualization.

Some advantages of the present invention over prior art are that thedissection tool has angled dissecting fingers to allow for unobstructedview of the surgical site, that the handles are offset from the centralaxis of the tool thereby allowing for additional unobstructed view ofthe surgical site, that the range of motion of the handles are designedin such a manner so that maximum squeezing forces apply duringdissection while opening the dissecting fingers, that the dissectingfingers of the instrument are concave in design through which surgicalinstruments can be passed to the vascular puncture site, that thefingers are broad to create a broad, clear channel, and that the accessconduit contains a rounded distal end which hugs the blood vessel andorients the conduit into an optimal access position, that the accessconduit contains a grooved bottom edge to guide the puncturinginstrument into an optimal central position on the vascular wall and canbe illuminated to provide better illumination, that the needleguide/illumination probe has a forked tip to engage the artery and holdit during puncture, and that the illumination probe contains a groovechannel to guide the needle to a centrally located point on the vascularwall.

While the invention has been described in its preferred embodiment, itis to be understood that the words which have been used are words ofdescription rather than limitation and that changes may be made withinthe purview of the appended claim without departing from the true scopeand spirit of the invention in its broader aspects.

It will be understood that the embodiments described herein are merelyexemplary and that a person skilled in the art may make many variationsand modifications without departing from the spirit and scope of theinvention. All such modification and variations are intended to beincluded within the scope of the invention as disclosed herein.

We claim:
 1. Apparatus for performing percutaneous entry to a bloodvessel or body structure comprising: dissector comprising: two armsdisposed in a first plane, a finger grip and a thumb grip at the end ofthe arms, a pair of dissecting fingers extending from the other ends ofthe arms disposed in a second plane at an angle to the first plane,pivot means connecting the arms to enable spreading of the dissectingfingers upon movement of the finger grip and thumb grip towards eachother, tapered passages formed on adjacent surfaces of the dissectingfingers, the tapered passages on the dissecting fingers coacting to forma cylindrical passage upon spreading of the dissecting fingers, aconduit comprising: a cylindrical tube having a distal and a proximalend, a longitudinal groove formed in the inner surface of the cylinderwall, the diameter of the outer wall of the conduit adapted to coactwith the cylindrical passage formed by the tapered passages of thedissecting fingers to allow sliding movement of the conduit in thecylindrical passage formed by the dissecting fingers, the distal end ofthe conduit formed at an angle relative to the angle of the second planein which the dissecting fingers lie so as to be substantially parallelto the first plane in which the arms of the dissector are disposed, anobturator comprising: an elongated mid-section, an end section formed onat least one of the ends of the mid-section, the obturator end sectionadapted to fit within the conduit in frictional sliding relation to theinner wall of the conduit, an end surface formed at the end of eachobturator end section, each end surface having an elliptical form shapedand disposed at an angle to register with the distal end of the conduit,the elongated mid-section constructed to allow passage of themid-section through the cylindrical passage formed by the coactingtapered passages of the dissecting fingers, a needle guide comprising:two wings joined at a central section having a distal and proximal end,the length of the wings greater than the length of the conduit andadapted for coaction of the needle guide within the conduit, ends of thewings at the distal end of the guide shaped to form separated pointsadapted to lie on and capture a blood vessel, a handle at the proximalend of the guide connected to one of the wings and extending away fromthe longitudinal axis of the guide, a groove running the length of thecentral section to act as a needle guide.
 2. Apparatus for performingpercutaneous entry to a blood vessel or body structure comprising: adissector comprising: two arms, a pair of dissecting fingers, pivotmeans connecting the arms to enable spreading of the dissecting fingers,the tapered passages on the dissecting fingers coacting to form acylindrical passage upon spreading of the dissecting finders, a conduitcomprising: a cylindrical tube having a distal and a proximal end, thediameter of the outer wall of the conduit adapted to coact with thecylindrical passage formed by the tapered passages of the dissectingfingers to allow sliding movement of the conduit in the cylindricalpassage formed by the dissecting fingers, an obturator comprising; anelongated mid-section, an end section formed on at least one of the endsof the mid-section, the obturator end section adapted to fit within theconduit in frictional sliding relation to the inner wall of the conduit,an end surface formed at the end of each obturator end section, a needleguide comprising, two wings joined at a central section having a distaland proximal end, the length of the wings greater than the length of theconduit and adapted for coaction of the needle guide within the conduit,a groove running the length of the central section to act as a needleguide.
 3. The apparatus claimed in claim 2, further comprising; thedissector has two arms disposed in a first plane, a finger grip and athumb grip at the end of the arms, the pair of dissecting fingersextending from the other ends of the arms disposed in a second plane atan angle to the first plane, the pivot means connecting the arms toenable spreading of the dissecting fingers actuate upon movement of thefinger grip and thumb grip towards each other.
 4. The apparatus claimedin claim 2, further comprising: the dissector has two arms disposed in afirst plane, a finger grip and a thumb grip at the end of the arms, apair of dissecting fingers extending from the other ends of the armsdisposed in a second plane at an angle to the first plane, the conduithas a cylindrical tube with: a longitudinal groove formed in the innersurface of the cylinder wall, and the distal end of the conduit formedat an angle complementary to the angle of the second plane in which thedissecting fingers lie so as to be substantially parallel to the firstplane in which the arms of the dissector are disposed.
 5. The apparatusclaimed in claim 2, further comprising the obturator having; an endsurface formed at least one end of the obturator, each end surfacehaving an elliptical form shaped and disposed at an angle to registerwith the distal end of the conduit, the elongated mid-sectionconstructed to allow passage of the mid-section through the cylindricalpassage formed by the coacting tapered passages of the dissectingfingers.
 6. The apparatus claimed in claim 2 further comprising theneedle guide having: the ends of the wings at the distal end of theneedle guide shaped to form separated points adapted to lie on andcapture a blood vessel, a handle at the proximal end of the guideconnected to one of the wings and extending away from the longitudinalaxis of the guide.